Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension...
Date First Received: August 22, 2006
Last Updated: May 30, 2008
Verified by: Novartis, May 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2006
Overall Status: Completed
Estimated Enrollment: 860
Brief Summary
Official Title: “A 36 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active-Controlled, Optional Titration Study Comparing an Aliskiren-Based Regimen to a Ramipril-Based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension”
Condition Keyword(s):
Intervention(s):
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Drug: aliskiren/ramipril
Outcome Measures for this Clinical Trial
Primary Measures
- Mean Sitting Systolic Blood Pressure lowering effect at baseline, week 12, week 36
Secondary Measures
- Mean sitting diastolic blood pressure (msDBP) lowering from baseline to week 12, week 36
- Cough at 12 and 36 weeks
- Adverse Events at 12 and 36 weeks
- Quality of Life at 12 and 36 weeks as assessed by the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form
- Safety and tolerability
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or female outpatients 65 years old or older.
- Patients with mild to moderate systolic hypertension.
- Patients who are eligible and consent to participate in the study
Exclusion Criteria:
- Severe hypertension
- History of CVA, TIA, MI or bypass surgery in the last 6 months
- Severe heart failure, severe chronic kidney disease or severe liver disease.
- Other protocol-defined inclusion/exclusion criteria may apply
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 65 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368277
Study ID Number: CSPP100A2344
ClinicalTrials.gov Identifier: NCT00368277
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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